CYCLATOP, a 5% cyclosporine topical spray, may be poised to deliver a significant therapeutic improvement for atopic dermatitis patients. A new study by researchers at the Hospital del Mar and the Autonomous University of Barcelona, Barcelona, Spain, suggests that applying this immunosuppressant medication topically via this spray may greatly outperform the drug’s current delivery vehicle.
The study included 44 mild-to-moderate atopic dermatitis patients (age range: 2–75 years) with a mean baseline body surface area involvement of 8.3%, with lesion areas of similar size and severity bilaterally. These patients were then treated with the topical spray on one side of the body twice daily, and with the common vehicle itself on the other side.
Results showed that the spray had increased efficacy. Eczema Area Severity Index (EASI) scores improved by an average of 3.2, from a mean baseline of 5.5, after 28 days of treatment, compared with 1.7 points for the vehicle treatment; similar results were reported using the Atopic Dermatitis Severity Index (ADSI), which improved from a mean baseline of 6.5 by 3.6 and 2.4 points, respectively. These improvements were seen to occur relatively quickly, with a 75% reduction from baseline EASI scores (EASI 75) achieved by 44.4% of spray-treated patients after 3 weeks, compared to 25.9% in the control group. Once again, this was mirrored in the ADSI results, with ADSI 75 rates of 33.3% and 11.1%, respectively, at 3 weeks.
These results represent a step towards being able to offer an alternative to corticosteroid therapy, which is particularly desirable for the paediatric population where parents are increasingly steroid-phobic. Since cyclosporine is such a large molecule, creating a suitable cream or ointment formulation was difficult; “the challenge was to find a stable formulation with good skin penetration, but without systemic absorption,” explained Dr Ana Giménez-Arnau, Hospital del Mar and the Autonomous University of Barcelona. It is hoped that this new oil emulsion formulation will offer fast-acting results to those patients with mild-to-moderate atopic dermatitis.